The Recall Desk
ModerateFDA (Devices)·Z-0743-2020·Announced 2020-01-01

Axis-Shield Homocysteine Reagent Recalled for Potential Performance Issues

Axis-Shield Diagnostics is recalling 740 units of Liquid Stable 2-Part Homocysteine Reagent due to potential performance issues detected during routine testing.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a potential performance issue without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Axis-Shield Diagnostics, Ltd. is recalling 740 units of Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent, Part Number FHRWR100. The recall is due to a potential performance issue identified as an under-recovery of sample results during routine testing.

The affected product is intended for professional use only and can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The recall covers units distributed nationwide in the states of California and Kentucky.

Healthcare professionals should stop using the affected product and contact Axis-Shield Diagnostics for further instructions. The specific lot number is 902924526, and the UDI is 05055845400169.

The recalled product

Product
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
Manufacturer
Axis-Shield Diagnostics, Ltd.
Category
Medical Device — Laboratory Reagent
Hazard
Affected units
740

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI: 05055845400169
  • Lot Number 902924526

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Axis-Shield Diagnostics, Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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